Change Control Specialist

CSL Behring Kankakee, IL
This position is part of the Change Management group and provides quality oversight for all changes associated with facilities, equipment, systems processes and materials while ensuring compliance with CSL procedures and cGMPs.

Job Description

Defines the implementation plan for changes and ensures all sequence steps within

change control are performed in correct order.

Evaluates change and risk to product SQuIPP. Determines if batch tracking is required.

Evaluates change for completeness and issues approval for change (Release to

Operation).

Participates in project teams (including shutdown teams) focused on the development and

improvement of existing, and the installation of, new equipment and systems.

Communicates and coordinates with representatives of Manufacturing, Validation,

Regulatory, Engineering, Compliance and other site personnel to obtain necessary

background information and technical data to assure timely review and completion of

change controls.

Reviews proposed changes, obtains additional clarification/information as necessary, and

ensures that all relevant supporting documentation for a given change control is included.

Facilitates meetings to gain consensus between impact reviewers. Negotiates

agreements on change conflict.

Assists Supervisor and Manager in identifying change control issues which need

correction or improvement. Also assists Supervisor and Manager in preparing and/or

conducting change control training, as required.

Reviews and tracks all change controls throughout the change control process utilizing

TrackWise. Obtains additional clarification/information as necessary and provides

pertinent feedback to change request initiators and management.

Review all risk assessments for completeness.

Perform the job duties of Document Control Specialist as requested.

Education

B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry,

biology, physics, engineering, computer science, technical writing) or experience

and training equivalent to such a degree.

Experience

Two or more years experience working in a cGMP regulated environment such as

the field of quality, manufacturing or engineering field, applying the cGMP rules in

everyday activities. Specific experience in the process of change control is

preferred.

Competencies

Knowledge of cGMP's and FDA guidelines required. Must demonstrate

competency in verbal and written communication. TrackWise and DCMS

computer application. Manufacturing process and FMEA Quality Risk Assessment

knowledge a plus.

Worker Type:

Employee

Worker Sub Type:

Regular